Events

ALBAclone Advanced Partial RhD Typing Kit. An in vitro diagnostic medical device (IVD) 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Haemokinesis Pty Ltd 에 의해 제조된 제품과 관련되어 있습니다.

이것은 무엇인가요?

의료기기에 문제가 생겼을 경우 제조사가 이를 바로잡거나 시장에서 회수하는 조치를 말한다. 회수(Recall)는 의료기기에 결함이 있거나, 건강에 위협이 되거나, 또는 결함도 있고 건강에도 위협이 될 경우에 발생한다.

데이터에 대해 더 자세히 알아보기 여기
  • 사례 유형
    Recall
  • 사례 ID
    RC-2017-RN-00628-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2017-05-25
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-00628-1
  • 비고 / 경고
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Australia.
  • 데이터 추가 비고
  • 원인
    The manufacturer has found that lot no v174693 has a reduced level of performance associated with components h and l, which are generating weaker than normal reactions with some weak rhd and partial rhd samples. reduced reactivity of components h and l is considered to make interpretation of the rhd variant sample type more difficult given results are available from only ten of the twelve monoclonal anti-d cell lines contained in the kit.
  • 조치
    Haemokinesis is advising users to quarantine and dispose of the affected lots. Haemokinesis will provide replacement stock or will issue a credit note. For previously generated results, the laboratory Medical Director should take into consideration the possible reduced reactivity of component H and L.

Device

ALBAclone Advanced Partial RhD Typing Kit. An in vitro diagnostic medical device (IVD)
  • 모델명 / 제조번호(시리얼번호)
    ALBAclone Advanced Partial RhD Typing Kit. An in vitro diagnostic medical device (IVD)Product Code: Z293Lot Number: V174693Expiry Date: 13 July 2017ARTG Number: 225063
  • Manufacturer
    Haemokinesis Pty Ltd

Manufacturer

Haemokinesis Pty Ltd